Analysis of Lipid Profiles in Samples Sperm and Seminal Plasma Under Artificial Insemination

Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm and seminal plasma linking the success or failure of the artificial insemination (IUI)

Study Overview

• Status: Withdrawn
• Conditions: Primary Infertility

Detailed Description

Analyze lipid profiles in samples of sperm and seminal plasma of three populations:

1. male sperm donors
2. men assigned to a program of assisted reproduction with normal sperm / slightly abnormal successfully in the IUI;
3. attached to a program of assisted reproduction with male semen Normal / slightly abnormal unsuccessfully in IUI

Establish partnerships between the composition of fatty acids, especially fatty acids polyunsaturated (PUFA) of the omega-3 (w3) series of samples analyzed parameterssemen and results of the IA to identify biochemical markers of fertility.

Assess markers found by checking the increase in the rate of success in the IA.

• Study Type: Observational

Contacts and Locations

Study Locations

• Spain
  • Vizcaya
    • Leioa, Vizcaya, Spain, 48940
      • IVI Bilbao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo cycles of artificial insemination with own semen. Donor semen samples are intended for cycles of artificial insemination of donor Once the technical and knowing the value of the ßhCG (indicating pregnancy hormone)determined up to a maximum of 4 treatments, the population for this study were divided into three groups

Description

Inclusion Criteria Group A women donor group

• Fallopian unobstructed Men donor group
• Appear as sperm donor
• Age between 18-35 years
• Sexual abstinence 3-5 days

Exclusion Criteria Group A:

• Uterine malformations (fibroids, adenomyosis, uterine malformations or acquired congenital) and fallopian tubes (tubal occlusion)
• Obesity BMI (Body Mass Index)> 30 kg / m2
• Presence of altered tubal toxic habits (smoking> 15 cigarettes per day, alcohol or drug abuse).

Inclusión / Exclusion Criteria Group B and C:

• ≤ 38 years
• Natural cycles and stimulated
• The criteria inclusion / exclusion group A
• Time sterility not exceeding three years.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Male donor; 42 samples of semen from male donor attached to a donation program Normal sperm count as WHO 2010.
IUI positive pregnancy; 42 samples of semen from a program attached to patients for insemination Male indication Normal / slightly abnormal sperm count or infertility source unknown and have obtained positive pregnancy in any of the first 4 treatments IUI
IUI unsuccessful pregnancy; 42 samples of semen from a program attached to patients for insemination Male indication Normal / slightly abnormal sperm count or infertility source unknown and after undergoing maximum 4 cycles have unsuccessfully IUI indication of IVF / ICSI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify, by Lipidomics approaches, biochemical markers of fertility / infertility sperm and seminal plasma linking the success or failure of the artificial insemination	Levels of docosahexaenoic acid (DHA) and acid eicosapentaenoic (EPA) in 42 semen samples: With positive pregnancy in any of the first 4 treatments of artificial insemination.; Gestacion Negative in artificial insemination; Assigned to the program-donors donation	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive analysis of semen parameters versus DHA and EPA levels	Correlation analysis of seminal variables: sperm count, motility and morphology percent compared to the levels of DHA and EPA obtained. Assuming normal distribution continuous variables, ANOVA test apply. If the normality assumption failed an Kruskal-Wallis test was applied.	18 months

Collaborators and Investigators

• Sponsor: IVI Bilbao
• Collaborators: University of the Basque Country (UPV/EHU)
• Investigators: Principal Investigator: Marcos Ferrando, MD, IVI Bilbao

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 505-BIO-035-MF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED